RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

CFDA Trial Data Quality Drive Leads to Rejection of Applications

China Food and Drug Administration (CFDA) has rejected 11 applications from eight manufacturers as part of its clampdown on the quality of clinical trial data included in submissions. The rejections come four months after CFDA began a drive to root out applications with incomplete or subpar data.

None of the manufacturers affected by the rejections recalled their applications voluntarily, a get-out route taken by many companies in the wake of CFDA’s commitment to scrutinize their trial data. Instead, CFDA identified perceived shortcomings with the datasets in support of the applications during on-site inspections of the manufacturers. The applications covered generic medicines to treat cardiovascular problems, schizophrenia, pain, infections and other disorders.

Industry executives are taking CFDA’s actions seriously. “CFDA seems very, very determined on this quality issue,” an anonymous senior executive at a multinational biopharma company told Reuters. “That could change the Chinese pharmaceutical industry in a big way.” One possible outcome is that the crackdown tips the market in favor of companies that are better equipped to comply with CFDA’s more stringent demands, such as multinational drugmakers and the larger local companies.

Hainan Pharmaceutical, Zhejiang Huahai Pharmaceutical, Hebei Pharmaceutical, Qingdao Bai Yang Pharmaceutical, Zhejiang Angli Kang Pharmaceutical, Hainan Kang Chi Pharmaceutical, Guangdong Pharmaceutical and Shandong Da Yinhai were the eight companies affected by the rejections. CFDA is also investigating contract research organizations and other groups involved in clinical trials as part of its push to eliminate the submission of data that fail to meet its standards.

If successful, the trial data quality drive will yield two benefits for CFDA. The most immediate impact will be the elimination of some applications from the massive and growing backlog facing CFDA. Further down the line, the trimming of the backlog should mean CFDA officials spend less time reviewing subpar filings and cut the risk of drugs supported by fraudulent data coming to market.

The Central Drugs Standard Control Organization (CDSCO) of India has officially begun its electronic submission program. CDSCO is introducing the system as part of a push to use technology to cut the time it takes to process applications for import approvals, clinical trial clearances and other licenses.

Jagat Prakash Nadda, the Indian minister of health and family welfare, presented the platform at an event this week. CDSCO is accepting applications for import and personal licenses through the portal, as well as submissions for permissions to run clinical trial. By moving the application process for these permissions online, CDSCO thinks it can make the regulatory process more consistent and transparent.

The use of the online platform is voluntary, meaning companies have an alternative way to submit applications to CDSCO if problems with the web portal affect their ability to make filings electronically. At the time of writing on Tuesday morning, the portal for submission of applications for clinical trial permissions, http://octams.gov.in, is down. The site was also down when Regulatory Focus first reported on the creation of the portal in September.

While the downtime suggests the online submission platform, like many new IT initiatives, is facing some issues, the Indian government sounds committed to the widespread use of electronic filings. Dr. G N Singh, the Drug Controller General of India (DCGI), told PharmaBiz this week that CDSCO will receive funding to integrate the various electronic platforms already put in place by state regulators. Singh is aiming to complete the e-governance initiative within nine months.

The Therapeutic Goods Administration (TGA) of Australia has proposed limiting the maximum pack sizes in which paracetamol is sold. If TGA’s proposal comes into force, paracetamol will be sold in packs of 100 tablets or fewer, with bulk offerings only provided to controlled environments.

Regulators typically limit the availability of over-the-counter paracetamol to reduce the risk of the drug being used in suicide attempts, although the 100-pill pack sizes proposed by TGA would still represent a potentially lethal dose. In the United Kingdom, paracetamol is sold outside of pharmacies in packs of 16 tablets or fewer, but it is possible to purchase multiple packets. Sweden has gone further still by banning the sale of paracetamol in convenience stores.

TGA is heading along a similar path. The proposal includes stipulations to limit the supply of bulk pack sizes of paracetamol to hospitals, nursing homes and “pharmacies for dispensing purposes,” environments which are unlikely to make the drug available in large quantities to people who may use it for self-harm. TGA is seeking feedback on the proposal until 10 December, after which it will decide whether to adopt the amendment and other proposed changes to the Poisons Standard.

The other proposed changes relate to ketoprofen, loratadine and naproxen. TGA wants to make doses of 200mg or less of naproxen available for sale outside pharmacies. The amendment to the standard covering loratadine would make tablets of 10mg or less available in packs of up to 10 pills. As it stands, such dosage forms are only available in packs of five tablets. The final change would add oral doses of 200mg or less of ketoprofen to Schedule 3.

The Philippines Food and Drug Administration (PFDA) has posted a warning about fake versions of a pediatric antibiotic. PFDA issued the alert after gathering evidence about the sale of copies of Abbott Laboratories’ Klaricid.

Laboratory analyses of the fakes has shown they contain none of the active ingredient in Klaricid, clarithromycin. Abbott has confirmed the products are fake, too. The packaging of the counterfeits reveals that they are not genuine in multiple ways, although the untrained eye may fail to spot these telltale signs, particularly if no authentic version of the product is available for comparison. PFDA has highlighted the ways in which the packaging of the counterfeits differs from Abbott’s Klaricid.

The printing quality is poor on the counterfeits and the color of the Abbott logo is different than on the real product. Smaller differences include the lack of the name of a PFDA-licensed importer on the counterfeits and the use of invalid lot details.

CFDA has published several documents relating to its ongoing attempts to overhaul its approach to drug registration. The documents include a call for comments on a proposal to deal with the backlog of applications facing CFDA and details of policies adopted to date. CFDA is accepting feedback on the proposal until 13 December. Draft Proposal, CFDA Notice, More (Chinese)

Japan Times has reported that Novartis is set to be punished for failing to report serious side effects on time. The Japanese health ministry is reportedly planning to issue a business improvement order to the Swiss drugmaker. If the order is sent, it would mark another blow for Novartis in Japan. Last year, the country suspended the company’s operations for 15 days. Japan Times

CFDA has issued a notice about medical devices containing silver, a metal used in such products because of its antimicrobial properties. The Chinese regulator used the notice to outline its new approach to medical devices containing silver and how it will affect manufacturers with products on the market and in development. CFDA Notice (Chinese)